NCT03977012招募中不适用
Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome(CRPS) Patients With Chronic Lower Back Pain: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in neuroinflammation
研究概览
简要总结
In the present study, we aim to investigate the effect of buprenorphine on neuroinflammation in patients with complex regional pain syndrome, using [11C]-(R)-PK11195 PET.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4).
- •Patients who can stop benzodiazepine treatment 2 weeks before study
- •Patients who initially decided to use buprenorphine according to clinical judgment
- •Patients who are able to understand the purpose and procedure of the study
排除标准
- •Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation
- •Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease
- •Patients with cardiovascular disease, liver, respiratory or renal dysfunction
- •Patients with biliary disease
- •Patients who could not undergo the PET/magnetic resonance imaging (MRI) process.
- •Patients who have a risk of suicide or show aggressive behavior
- •Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older)
- •Employees of researchers or clinical research institutes
- •Patients with hypersensitivity or contraindication to buprenorphine
研究组 & 干预措施
Patients with CRPS Type I
Patients diagnosed with Complex Regional Pain Syndrome Type I who are anticipated to recieve a 8 weeks regime of buprenorphine as a part of routine medical care.
-drug name: norspan patch 5~20 mcg dosage form: patch frequency: every weeks duration: 8 weeks
干预措施: Buprenorphine (Drug)
结局指标
主要结局
Changes in neuroinflammation
时间窗: baseline, 8 weeks
\[11C\]-(R)-PK11195 PET distribution volume ratio (DVR)
次要结局
- Morphine equivalent(baseline, 8 weeks)
- Physical test(1)(baseline, 8 weeks)
- Physical test(2)(baseline, 8 weeks)
- Physical test(3)(baseline, 8 weeks)
- Physical test(4)(baseline, 8 weeks)
- Physical test(5)(baseline, 8 weeks)
- Self-reported questionnaire(3)(baseline, 8 weeks)
- Self-reported questionnaire(1)(baseline, 8 weeks)
- Self-reported questionnaire(2)(baseline, 8 weeks)
- Self-reported questionnaire(4)(baseline, 8 weeks)
研究者
Soo-Hee Choi
Associate Professor
Seoul National University Hospital
研究点 (1)
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